Gallbladder implants and systems and methods for the delivery thereof

ABSTRACT

A filter device for implantation in a gallbladder, comprising: a filtering portion configured to filter gallstones of a certain minimum size to prevent them from exiting the gallbladder through an opening of the gallbladder; a tail extending from the filtering portion away from the opening of the gallbladder and towards a distal wall of the gallbladder; and, a stopper located at a distal end of the tail, near the distal wall of the gallbladder when the filter device is implanted; wherein the filtering portion, stopper and the tail are configured to be of an overall length within the gallbladder that they, when taken together, extend substantially the length of the gallbladder from the distal wall to the opening of the gallbladder to prevent migration of the filtering portion away from the opening of the gallbladder.

RELATED APPLICATION/S

This application claims the benefit of priority under PCT Article 8 ofU.S. patent application Ser. No. 15/147,080 filed on May 5, 2016, and isrelated to PCT application PCT/IL2015/051051, filed on Oct. 27, 2015,which claims the benefit of priority under PCT Article 8 of ProvisionalPatent Application No. 62/069,164 filed Oct. 27, 2014; this applicationis also related to pending U.S. patent application Ser. No. 15/140,505filed on Apr. 28, 2016, and PCT application PCT/IL2017/050384 filed onMar. 28, 2017, the contents of all of which are incorporated byreference herein in their entireties.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates generally to treating medical conditionsinvolving ducts and/or body lumens, for example by preventing occlusionof portions of the biliary tree during treatment device deployment.

“Stones” in the gallbladder and bile ducts are found in the entirepopulation, some of them being asymptomatic, and some—symptomatic. Inthe U.S., 10-15% of the adult population (more than 20 million people)suffer from bile duct stones (about 20% of the population above 65 yearsof age suffer from gallstones), with more than two million new casesdiagnosed annually, and more than 1,800,000 cholecystectomy proceduresperformed annually. Patients with gallstones are classified according tothree groups: symptomatic, asymptomatic and those suffering fromcomplications caused by the gallstones, such as cholecystitis,pancreatitis or obstructive jaundice.

SUMMARY OF THE INVENTION

There is provided in accordance with an exemplary embodiment of theinvention, a filter device for implantation in a gallbladder,comprising: a filtering portion configured to filter gallstones of acertain minimum size to prevent them from exiting the gallbladderthrough an opening of the gallbladder; a tail extending from thefiltering portion away from the opening of the gallbladder and towards adistal wall of the gallbladder; and, a stopper located at a distal endof the tail, near the distal wall of the gallbladder when the filterdevice is implanted; wherein the filtering portion, stopper and the tailare configured to be of sufficient overall length within the gallbladderthat they, when taken together, prevent migration of the filteringportion away from the opening of the gallbladder.

In an embodiment of the invention, the filtering portion, tail andstopper are configured to fit entirely and substantially uncompressedwithin the gallbladder.

In an embodiment of the invention, the filtering portion is comprised ofspherical, circular, ovoid or oblong leaves.

In an embodiment of the invention, at least some of the leaves overlapat least partially.

In an embodiment of the invention, the stopper is split into at leasttwo tails, each tail configured with its own stopper.

In an embodiment of the invention, the stopper is mushroom-shaped,biased towards the opening of the gallbladder.

In an embodiment of the invention, the stopper is coil-shaped.

In an embodiment of the invention, the stopper is resilient.

In an embodiment of the invention, the stopper is configured with atleast two concentric circles.

In an embodiment of the invention, the filter device is comprised of asingle filament.

In an embodiment of the invention, two loose ends of the single filamentare attached together.

In an embodiment of the invention, the two loose ends are weldedtogether.

In an embodiment of the invention, the filter device is configured suchthat the two loose ends are attached together along the tail.

In an embodiment of the invention, the device is made from at least oneof a metal, a shape memory alloy and a polymer.

In an embodiment of the invention, the device is adapted for eluting apharmaceutical after implantation.

In an embodiment of the invention, the device is at least one ofbioabsorbable and biodegradable.

In an embodiment of the invention, at least one of the stopper andfiltering portion are configured to prevent bio-film growth.

In an embodiment of the invention, the filtering portion is configuredto filter gallstones 5 mm or greater in diameter.

In an embodiment of the invention, the stopper is configured to pushgallstones of a certain minimum size away from the opening of the gallbladder.

There is further provided in accordance with an exemplary embodiment ofthe invention, a system for delivery of a filter device for implantationin a gallbladder, comprising: a filter device including a stopper; aguiding rod around which the filter device is at least partiallywrapped; and, a catheter with an opening at a distal end, through whichthe guiding rod and filter device are inserted, configured for transitto the gallbladder.

In an embodiment of the invention, the filter device is wrapped on aside of the guiding rod, such that the filter device is deployable inthe gallbladder without retraction of the guiding rod.

There is further provided in accordance with an exemplary embodiment ofthe invention, a method for implanting a filter device in a gallbladder,comprising: navigating the filter device wrapped around a guiding rodthrough an opening to the gallbladder for implantation, the filterdevice including at least a filtering portion, a tail and a stopper;withdrawing at least partially a catheter, through which the guiding rodand filter device are inserted, from the implantation site; expanding atleast a portion of the filter device at least partially; and,withdrawing the guiding rod from the implantation site, leaving theexpanded filter device entirely within the gallbladder and substantiallyuncompressed, wherein the filtering portion is disposed proximal to theopening of the gallbladder and the stopper is disposed proximal to adistal wall of the gallbladder opposite the opening after implantation.

In an embodiment of the invention, the expanding includes expanding thestopper then pushing gall stones towards the distal wall prior toexpanding of the filtering portion.

In an embodiment of the invention, the pushing is performed by at leastone of the guiding rod and the stopper.

In an embodiment of the invention, the filter device is implanted suchthat an attachment between two loose ends of the single filament filterdevice does not abut a wall of the gallbladder.

There is further provided in accordance with an exemplary embodiment ofthe invention, a filter device for implantation in a gallbladder,comprising: a filtering portion configured with a plurality of at leastpartly overlapping leaves to prevent gallstones of a certain minimumsize from exiting the gallbladder through an opening of the gallbladder;at least one tail extending from the filtering portion away from theopening of the gallbladder and towards a distal wall of the gallbladder;and, at least one stopper located at a distal end of the at least onetail, near the distal wall of the gallbladder when the filter device isimplanted; wherein the filtering portion, stopper and the tail areconfigured to be of sufficient overall length within the gallbladderthat they, when taken together, prevent migration of the filteringportion away from the opening of the gallbladder, and, wherein thefilter device is constructed of a single wire with two loose endsattached together.

There is further provided, a method of deploying a filtering device in agallbladder, comprising: navigating a guide wire to an implantation sitein the gallbladder; placing an external catheter containing thefiltering device over the guide wire; advancing the external catheterand the filtering device in a distal direction along the guide wire tothe implantation site; and, deploying at least a blocking portion of thefiltering device out of the external catheter.

In an embodiment of the invention, the deploying includes pushing atleast one gall stone away from a gallbladder opening towards a distalwall of the gallbladder with the blocking portion.

In an embodiment of the invention, placing further comprises placingover the guide wire, a tip on the distal end of the external catheter.

In an embodiment of the invention, the advancing further comprises usingthe tip to assist with the advancing to the implantation site.

In an embodiment of the invention, the method further comprises usingmedical imaging to image the guide wire and verify proper placement ofthe guide wire at the implantation site.

In an embodiment of the invention, the method further comprisesretracting the external catheter to deploy at least the blocking portionof the filtering device.

In an embodiment of the invention, the method further compriseswithdrawing everything but the filtering device from the gallbladder.

There is further provided, a filtering device for implantation in agallbladder, comprising: an egg or ovoid shaped body configured totransition from a collapsed configuration to an expanded egg or ovoidshaped configuration; wherein the body is formed from at least one eggor ovoid shaped coil of wire forming an interior space within the coilfor trapping gall stones.

In an embodiment of the invention, the body does not exert pressure, inthe expanded configuration, on a wall of the gallbladder.

In an embodiment of the invention, the filtering device is comprised ofa single wire.

In an embodiment of the invention, the coil of wire is denser on aproximal end of the filtering device near an opening of the gallbladder.

In an embodiment of the invention, the coil of wire is continuous.

In an embodiment of the invention, two ends of a linear coil of wire arewelded together to form the ovoid or egg shape.

In an embodiment of the invention, the coil of wire is 0.05 mm-0.35 mmthick.

In an embodiment of the invention, the filtering device furthercomprises an internal blocking portion disposed in the interior space ofthe filtering device.

In an embodiment of the invention, the filtering device is comprised ofa single wire.

In an embodiment of the invention, the internal blocking portion is eggor ovoid shaped.

In an embodiment of the invention, the filtering device furthercomprises a mesh structure disposed on a proximal side of the filteringdevice near a gallbladder opening.

In an embodiment of the invention, the mesh structure comprises aplurality of leaf or petal shapes.

In an embodiment of the invention, the body is formed from a pluralityof wires, the ends of which are joined together by at least one joiningring.

In an embodiment of the invention, the filtering device furthercomprises at least one indentation formed by a curvature of the wires.

There is further provided, a filtering device deployment system,comprising: an external catheter formed in a hollow cylindrical shape; acentral cylinder configured for insertion into and through the externalcatheter; a filtering device; and, a release wire, biased to bestraight, disposed near a distal end of the central cylinder and withinthe external catheter, wherein the release wire is releasably hookedaround a portion of the filtering device to retain the filtering devicewithin the external catheter.

In an embodiment of the invention, the filtering device deploymentsystem further comprises a ring disposed near and around the distal endof the central cylinder.

In an embodiment of the invention, the release wire is attached to thering.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example, and not necessarily to scale,and are for purposes of illustrative discussion of embodiments of theinvention. In this regard, the description taken with the drawings makesapparent to those skilled in the art how embodiments of the inventionmay be practiced.

In the drawings:

FIGS. 1A-1E are side views of a schematic deployment sequence of ablocking device, in accordance with an exemplary embodiment of theinvention;

FIGS. 2A-2C are side views of a schematic deployment sequence of afiltering device after the blocking sequence shown in FIGS. 1A-1E hasbeen performed, in accordance with an exemplary embodiment of theinvention;

FIGS. 3A-3C are side views of two tier filtering devices, in accordancewith exemplary embodiments of the invention;

FIGS. 4A-4C are top views of the filtering portion of filtering devices,in accordance with exemplary embodiments of the invention;

FIGS. 5A and 5B are perspective views of a filtering device, inaccordance with an exemplary embodiment of the invention;

FIG. 5C is a side view of a filtering device delivery system, inaccordance with an exemplary embodiment of the invention;

FIG. 5D is a side view of a filtering device delivery system with thefiltering device partially deployed, in accordance with an exemplaryembodiment of the invention;

FIG. 6 is a top view of a filtering device in situ, in accordance withan exemplary embodiment of the invention;

FIG. 7 is a flowchart of a method of deploying a filtering device in agallbladder, in accordance with an exemplary embodiment of theinvention;

FIG. 8 is a flowchart of a method of deploying a filtering device in agallbladder, in accordance with an exemplary embodiment of theinvention;

FIG. 9A is a side view of a filtering device with dense leaves and asplit stopper, in accordance with an exemplary embodiment of theinvention;

FIG. 9B is a side view of a filtering device with large overlappingleaves, in accordance with an exemplary embodiment of the invention;

FIGS. 10A-10C are side views of different stopper configurations, inaccordance with exemplary embodiments of the invention;

FIGS. 11A-11C are side views of a schematic deployment sequence of afiltering device, in accordance with exemplary embodiments of theinvention;

FIG. 12 is a side view of an egg-shaped filtering device, in accordancewith exemplary embodiments of the invention;

FIG. 13 is a side view of a double layered egg-shaped filtering device,in accordance with exemplary embodiments of the invention;

FIG. 14 is a side view of an asymmetrically meshed egg filtering device,in accordance with exemplary embodiments of the invention;

FIGS. 15A-15B are side views of ringed, egg-shaped filtering devices, inaccordance with exemplary embodiments of the invention;

FIG. 16 is a side view of a two layered filtering device, in accordancewith exemplary embodiments of the invention;

FIGS. 17A-17D are side views of a schematic deployment sequence of afiltering device, in accordance with exemplary embodiments of theinvention;

FIG. 18 is a flowchart of a method of deploying of a filtering device,in accordance with an exemplary embodiment of the invention;

FIG. 19 is a plan view of at least a part of a filtering device, inaccordance with an exemplary embodiment of the invention;

FIG. 20A-20C are side views of filtering devices, in accordance withsome exemplary embodiments of the invention; and,

FIGS. 21A-21B are plate and tube cutting patterns for filtering devices,in accordance with exemplary embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention relates generally to treating medical conditionsinvolving ducts and/or body lumens, for example by preventing occlusionof portions of the biliary tree during treatment device deployment.

In an aspect of the invention, there is provided a filter device forimplantation in a gallbladder, comprising: a filtering portionconfigured to filter gallstones of a certain minimum size to preventthem from exiting the gallbladder through an opening of the gallbladder;a tail extending from the filtering portion away from the opening of thegallbladder and towards a distal wall of the gallbladder; and, a stopperlocated at a distal end of the tail, near the distal wall of thegallbladder when the filter device is implanted; wherein the filteringportion, stopper and the tail are configured to be of sufficient overalllength within the gallbladder that they, when taken together, preventmigration of the filtering portion away from the opening of thegallbladder.

In an aspect of the invention, there is provided a system for deliveryof a filter device for implantation in a gallbladder, comprising: afilter device including a stopper; a guiding rod around which the filterdevice is at least partially wrapped; and, a catheter with an opening ata distal end, through which the guiding rod and filter device areinserted, configured for transit to the gallbladder.

In an aspect of the invention, there is provided a method for implantinga filter device in a gallbladder, comprising: navigating the filterdevice wrapped around a guiding rod through an opening to thegallbladder for implantation, the filter device including at least afiltering portion, a tail and a stopper; withdrawing at least partiallya catheter, through which the guiding rod and filter device areinserted, from the implantation site; expanding at least a portion ofthe filter device at least partially; and, withdrawing the guiding rodfrom the implantation site, leaving the expanded filter device entirelywithin the gallbladder and substantially uncompressed, wherein thefiltering portion is disposed proximal to the opening of the gallbladderand the stopper is disposed proximal to a distal wall of the gallbladderopposite the opening after implantation.

In an aspect of the invention, there is provided a filter device forimplantation in a gallbladder, comprising: a filtering portionconfigured with a plurality of at least partly overlapping leaves toprevent gallstones of a certain minimum size from exiting thegallbladder through an opening of the gallbladder; at least one tailextending from the filtering portion away from the opening of thegallbladder and towards a distal wall of the gallbladder; and, at leastone stopper located at a distal end of the at least one tail, near thedistal wall of the gallbladder when the filter device is implanted;wherein the filtering portion, stopper and the tail are configured to beof sufficient overall length within the gallbladder that they, whentaken together, prevent migration of the filtering portion away from theopening of the gallbladder, and, wherein the filter device isconstructed of a single wire with two loose ends attached together.

In an aspect of the invention, there is provided a method of deploying afiltering device in a gallbladder, comprising: navigating a guide wireto an implantation site in the gallbladder; placing an external cathetercontaining the filtering device over the guide wire; advancing theexternal catheter and the filtering device in a distal direction alongthe guide wire to the implantation site; and, deploying at least ablocking portion of the filtering device out of the external catheter.

In an aspect of the invention, there is provided a filtering device forimplantation in a gallbladder, comprising: an egg or ovoid shaped bodyconfigured to transition from a collapsed configuration to an expandedegg or ovoid shaped configuration; wherein the body is formed from atleast one egg or ovoid shaped coil of wire forming an interior spacewithin the coil for trapping gall stones.

In an aspect of the invention, there is provided a filtering devicedeployment system, comprising: an external catheter formed in a hollowcylindrical shape; a central cylinder configured for insertion into andthrough the external catheter; a filtering device; and, a release wire,biased to be straight, disposed near a distal end of the centralcylinder and within the external catheter, wherein the release wire isreleasably hooked around a portion of the filtering device to retain thefiltering device within the external catheter.

Generally, systems, devices and methods for deploying filtering devicesin a gallbladder and filtering devices themselves are described. In someaspects of the invention, a blocking device and/or a blocking portion ofa device are used to push gall stones away from the opening to thegallbladder in order to make space for proper deployment of a gall stonefiltering device. In some embodiments of the invention, the blockingdevice and the filter device are components of a system. In someembodiments of the invention, the blocking device is separate from thefiltering device. In some embodiments of the invention, the blocking isperformed by a filtering portion of the filtering device. In someembodiments of the invention, the filtering device is two-tiered.Optionally, one tier is configured to block and/or filter. Optionally,one tier is configured to anchor the device. In some embodiments of theinvention, the device is provided with a stopper, optionally on a distalend of a tail, wherein the tail, the stopper and/or thefiltering/blocking section prevent substantial migration of the filterdevice away from an opening to the gallbladder.

In an aspect of some embodiments of the invention, some or all of agallbladder filter device is constructed of a single wire or filament.In an embodiment of the invention, the single wire filter device ismanufactured by placing a plurality of bends or curves in the wire (forexample, forming the leaves of a filter portion and/or the curvature ofa stopper). Optionally, the filter device is completed by attaching twoloose ends of the wire together, for example by welding. It should beunderstood that an advantage of a single wire device is that thereresults in only one seam in the device which needs to be closed,representing an advantage in manufacturing.

It should also be understood that since seams may be more traumatic tobody tissue than the rest of the device (which is probably smoother),the fewer the number of seams the better from a patient health and/ordevice utilization standpoint. In some embodiments of the invention, thejunction between the two loose ends, which are attached to each other,occurs along a portion of the filter device that will not abut bodytissue. In an embodiment of the invention, the filter device isimplanted in the patient such that the seam is not proximal to, or doesnot abut, body tissue.

In some aspects of some embodiments of the invention, the devicesdescribed herein spare the patient from suffering and/or surgery, andare intended to prevent the complications of cholecystectomy andanesthesia, operative mortality, postoperative infections (woundinfection and other infections), and/or delayed impacts of gallbladderabsence (impaired absorption, abdominal pain, etc.) by relieving and/orpreventing the symptoms of cholecystitis, pancreatitis or obstructivejaundice, and/or preventing and/or delaying the need for cholecystectomyin patients with gallstones. In some embodiments of the invention,temporary relief, for example of pain induced by gallstones, isprovided.

It should be understood that exemplary filter devices described hereinare intended to prevent gallstones from passing from the gallbladderinto the cystic duct while still allowing for normal bile flow and/orbodily fluids and/or secretions through the biliary tree and into theduodenum. In some exemplary embodiments of the invention, filtering isachieved without exerting potentially harmful levels of expansive radialforce on the walls of the cystic duct and/or gallbladder. In someembodiments of the invention, no radial force is applied on the walls ofthe cystic duct and/or gallbladder.

Throughout the description, “proximal” or “proximally” means in thedirection closest to outside of the patient's body and “distal” or“distally” means in the opposite direction, that is in the directionfurther into the patient's body.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings. The invention is capable of otherembodiments or of being practiced or carried out in various ways.

FIGS. 1A-1E are side views of a schematic deployment sequence of ablocking device 100, in accordance with an exemplary embodiment of theinvention. For efficiency, description of device embodiments of theinvention (FIGS. 1A-1E and FIGS. 2A-2C) are described in conjunctionwith the methods of their deployment, in conjunction with FIG. 7.

FIG. 7 is a flowchart 700 depicting a method of implanting a filterdevice 200 in the gallbladder 104, in accordance with an embodiment ofthe invention. In an embodiment of the invention, implantation may beperformed without general anesthesia and is considered to be minimallyinvasive. In an embodiment of the invention, the filter device 200and/or the blocking device 100 are inserted and/or navigated (702) intothe GI tract via the mouth, through to the esophagus, through to thestomach and then into the duodenum. Navigation and/or insertion areaccomplished using an endoscope and/or a flexible guide wire/guiding rodand/or an elongated tool, such as a catheter 106, as chosen by theattending medical professional performing the procedure, in anembodiment of the invention.

The filter device 200 is advanced the Sphincter of Oddi/papila into thecommon bile duct, in an exemplary embodiment of the invention. Asphincterotomy of the Sphincter of Oddi is performed, if required and/ordesired, similarly to the method commonly used in endoscopy and ERCP.The filter device 200 is implanted at a desired implantation site bynavigating the filter device 200 from the common bile duct through tothe cystic duct and/or the gallbladder 104. Contrast material in usedorder to image the gallbladder 104 and/or the cystic duct and/or thegastro-intestinal tract, in some exemplary embodiments of the invention.Optionally, other commonly available imaging techniques are used for theimplantation, for example X-ray and/or ultrasound.

In an exemplary embodiment of the invention, the filter device 200and/or the blocking device 100 are inserted and/or navigated (702) intothe patient in a contracted form. In some embodiments of the invention,the blocking device 100 precedes the filter device 200 such that duringimplanting, the blocking device 100 enters (704) the gallbladder 104first (shown in FIGS. 1A-1B), radially expands (706) in the gallbladder104 (shown in FIGS. 1C-1D) and pushes (708) any gallstones 102 in thegallbladder 104 down to or at least towards a distal end of thegallbladder 104 and away from the gallbladder opening (shown in FIGS.1D-1E), thereby clearing a space within the gallbladder for properand/or full expansion of the filter device.

In an embodiment of the invention, the filter device 200 is thenintroduced (710) to the gallbladder 104 (now that the area in thegallbladder 104 near the opening has been cleared or substantiallycleared of gallstones 102) so that the filter device 200 can properlyexpand (712) to provide filtering. Introduction of the filter device 200and expansion in a cleared area is schematically shown in FIGS. 2A-2C.In some embodiments of the invention, the filter device 200 expands(712) to its intended size and shape upon arrival at the desired site ofimplantation.

In some embodiments of the invention, the filter device 200 is alsoprovided with blocking capability and functionally operates to bothblock (to clear out gall stones to make room for filter expansion) andfilter. Exemplary devices for performing both functions in the samedevice are shown and described with respect to FIGS. 3A-3C and FIGS.4A-4C, below. In some embodiments of the invention, the blocking device100 also functions as a filter, in addition to and/or alternatively tothe filtering device 200.

In some embodiments of the invention, the filter device 200 expands(712) as a consequence of its own spring-like behavior, for example upondeployment from a catheter 106 which was used to pass the filter device200 to the cystic duct and/or gallbladder 104, the device 200 springsinto designed shape and size once the catheter 106 is no longer holdingthe filter device 200 in a contracted state. Optionally, the filterdevice 200 expands (712) as a result of its shape memory characteristic.In some embodiments of the invention, an expansion balloon is used toexpand the filter device 200. Due to the special anatomic structure ofthe cystic duct in the gallbladder region, more than one balloon and/orone balloon inflation may be used, for example, using a flexible balloonfor initial inflation and a rigid and/or a semi-rigid balloon for filterdevice fixation.

Optionally, the blocking device 100 is withdrawn after the filter device200 has been deployed, for example through an opening in the filterdevice configured for passage of the blocking device 100 therethrough.Optionally, the opening is elastic, sphincter-like, and/or at leastpartially closes after the blocking device 100 passes through whilebeing withdrawn.

Besides the implantation method described above, any other techniqueleading to the Sphincter of Oddi and/or the gallbladder 104, such aslaparoscopy or open surgery, may be used.

In an embodiment of the invention, the filter device 200 and/or theblocking device 100 can be removed or are designed to be bio-absorbed atany time.

In some embodiments of the invention, medical imaging is used forguiding the navigation of the biliary tree and/or implantation of theblocking device 100 and/or filter device 200 at the correct implantationsite. Optionally, a scope is used to provide imaging. Optionally, x-rayis used to provide imaging. Optionally, ultrasound is used to provideimaging.

FIGS. 3A-3C are side views of two tier filtering devices 300, 320, 340,respectively, in accordance with exemplary embodiments of the invention.In an embodiment of the invention, the two tier filtering devices 300,320, 340 are provided with a combination filter/blocker portion 302,322, 342, respectively and an anchoring portion 304, 324, 344,respectively.

In an embodiment of the invention, the filter/blocker portion 302, 322,342 is configured to enter the gallbladder 104 prior to the second tier,or anchoring portion 304, 324, 344, which when the filter/blockerportion 302, 322, 342 expands pushes any gallstones away from theopening of the gallbladder 104, both to prevent gall stones fromentering the biliary tree and also to ensure proper deployment/expansionof the anchoring portion 304, 324, 344.

In an embodiment of the invention, the anchoring portion does not exertradial force on the wall of the gallbladder 104 and/or does not anchorby attaching itself or latching onto a wall of the gallbladder 104. Insome embodiments of the invention, the anchor portion 304, 324, 344works in combination with a stopper 306, 326, 346 which when takentogether stretch substantially the length of the gallbladder 104,preventing the devices 302, 320, 340 from moving axially in thegallbladder (that is, preventing the device from migrating away from theopening to gallbladder).

FIGS. 4A-4C are top views of the filter/blocking portions 302, 322, 342of filtering devices 300, 320, 340, in accordance with exemplaryembodiments of the invention. In some embodiments of the invention, atleast the filter/blocking portion 302, 322, 342 is configured so thatthere is spacing between the wires sufficient for blocking gallstones ofa specified minimum size, but are also far enough apart to avoid growthof bacterial films, and other bio-film growth, between the wires whichcould block the natural flow of material from the gallbladder into thebiliary tree.

In some embodiments of the invention, the filter/blocking portion isconfigured to block gallstones approximately 5mm or more in diameter. Insome embodiments of the invention, spaces between wires form an openingno greater than 4 mm×4 mm.

In some embodiments of the invention, the filter portion and/or blockingportion and/or anchoring portion are mesh, spiral/coiled and/or aperforated sheet. In some embodiments of the invention, the device isshaped to allow for slight movement within the implantation site inorder to prevent or delay bio-film growth via device motion. Optionally,the device is moved by movement of the gallbladder and/or thesurroundings of the implantation site itself. In an embodiment of theinvention, the device moves and/or flexes to cause any accumulation ofbio-film to break, crack and/or at the very least create openingsthrough the bio-film such that natural secretions of the gallbladdercontinue to flow.

The device material is selected to be biocompatible and/orbio-absorbable, in an exemplary embodiment of the invention. Optionally,the device is constructed of a polymer material. In some embodiments ofthe invention, the device is at least partly metal. Optionally, thedevice is at least a shape memory alloy such as nickel titanium, alsoknown as Nitinol®. In some embodiments of the invention, at least aportion of the device is coated, for example with Teflon® or othersimilarly inert or highly non-reactive coating. Optionally, at least aportion of the device and/or the coating is adapted to elute asubstance, for example a pharmaceutical. Optionally, an anti-bio-filmagent, like an antibiotic, is eluted from and/or covers at least aportion of the device.

In some embodiments of the invention, the entire device is constructedof a single filament. In an embodiment of the invention, the blockingportion (if separate, such as in the case of the device shown in FIGS.1A-1E) and/or the filter portion and/or anchoring portion are separatelyformed elements which are connected together. In some embodiments of theinvention, at least two of the portions are connected by at least asingle filament. Optionally, at least two of the sections are connectedby a plurality of filaments.

Optionally, the anchoring portion 304, 324, 344 could have aconfiguration shown in any of FIGS. 4A-4C. Optionally, a separateblocking or filter portion could have a configuration shown in any ofFIGS. 4A-4C.

FIGS. 5A and 5B are perspective views of a filtering device 500, inaccordance with an exemplary embodiment of the invention. FIG. 5B showsan exemplary filtering device 500 configured with a filter/blockingportion 502 and a stopper 504. FIG. 5A is a perspective view of across-sectioned gallbladder 104 with the filtering device 500 implantedwithin the gallbladder 104. In an embodiment of the invention, filteringdevice 500 is deployed after a blocking device 100 has been deployed.Optionally, the blocking device 100 is removed after the filteringdevice 500 has been placed in the gallbladder 104. In some embodimentsof the invention, the filter/blocking portion 502 is located near anopening 506 to the gallbladder 104 to prevent gallstones 102 of acertain minimum size from leaving the gallbladder 104. In someembodiments of the invention, the stopper 504 is configured to avoidpuncturing a wall of the gallbladder, for example by having a roundedshape. In some embodiments of the invention, the stopper 504 (includingthe length of filament leading to the stopper) and the filter/blockingportion 502 operate in conjunction (by substantially stretching thelength of the gallbladder) to reduce the chance of movement of thefilter/blocking portion 502 from migrating away from the opening 506.

FIG. 5C is a side view of a filtering device delivery system 550 forimplanting a filtering device, for example filtering device 500, inaccordance with an exemplary embodiment of the invention. Forefficiency, the filtering device delivery system 550 of FIGS. 5C and 5Dis described in conjunction with the a method of deploying a filteringdevice in a gallbladder shown in the flowchart 800 of FIG. 8. It shouldbe understood, that while filtering device 500 is shown in FIGS. 5C and5D, any of the filtering devices or filtering device variationsdescribed herein could be used and/or deployed as described herein. Inan embodiment of the invention, a conventional delivery system for abiliary stent is used for delivery of a filtering device 500 (or any ofthe filtering devices described herein).

In some embodiments of the invention, the delivery system includes acatheter 552, within which a guiding rod 554 with a tip 556 mounted on adistal end of the guiding rod 554 is inserted. In some embodiments ofthe invention, the tip 556 is used for assisting with the navigation(802) of the catheter 552 within the patient to an implantation site,for example in the gallbladder. Optionally, the tip is configured toassist with the blocking of stones within the gallbladder during filterdevice 500 deployment, for example with reversibly deployablestructures. In an embodiment of the invention, filtering device 500 iswrapped around guiding rod 554, between the guiding rod 554 and thecatheter 552 (so the body of the patient is shielded from the filteringdevice). In some embodiments of the invention, filtering device 500 isplaced substantially on one side of the guiding rod 554 (and temporarilytrapped there by the catheter 552), such that deployment of thefiltering device 500 is from the side when the catheter 552 is retractedinstead of longitudinally axially. A substantially side-mountedfiltering device 500 is shown in FIG. 5D, described in more detailbelow. It should be understood that side-mounting the filtering device500 enables the retention of the guiding rod 554 in the implantationsite while still allowing the device 500 to deploy. As describedelsewhere, retention of the guiding rod 554 at least facilitateslocating the device 500 within the implantation site or facilitatespushing stones distally in the gallbladder for unimpeded device 500deployment, in an embodiment of the invention.

FIG. 5D is a side view of the filtering device delivery system 550 withthe filtering device 500 partially deployed, in accordance with anexemplary embodiment of the invention. In an embodiment of theinvention, the catheter 552 has been withdrawn (804) partially in aproximal direction, leaving the guiding rod 554, around which thefiltering device 500 is wrapped, proximal to the implantation site. Asthe catheter 552 is withdrawn further, more and more of the filteringdevice 500 is deployed into the implantation site and at least partiallyexpands (806) into shape. For example, the stopper 504 of filteringdevice 500 has assumed a loop configuration having been freed from thecatheter 552, whereas it was compressed for delivery when it was withinthe catheter 552 and wrapped around the guiding rod 554. In someembodiments of the invention, the deployed stopper 504 (or otherstoppers 1000, 1010, 1020 described herein) pushes (808) gall stonesdown in the gallbladder towards the distal wall of the gallbladder inorder to provide sufficient space within the gallbladder near thegallbladder opening for unimpeded expansion of the filtering portion ofthe device 500. In an embodiment of the invention, the filtering device500 when fully expanded and deployed will resemble the filtering device500 depicted in FIG. 5B. In an embodiment of the invention, the guidingrod 554 is also withdrawn (810) from the implantation site, once thefiltering device 500 has been fully deployed, leaving the filteringdevice 500 by itself within the implantation site, or gallbladder.

In some embodiments, pushing (808) is achieved by holding the catheter552 in relative place while the filter device 500 is deployed stopperfirst and/or the guiding rod 554 is advanced distally. In someembodiments of the invention, the blocking portion/pusher are a part ofthe filter device, such as described herein, and/or are a part of thedelivery system (e.g. the catheter or guiding rod). In some embodimentsif the invention, the guiding rod 554 is used to assist with locatingthe filter device within the gallbladder or implantation site, forexample where the filter device is wrapped around the guiding rod priorto deployment the guiding rod can located the filter device at aparticular depth of insertion, or even direction of insertion, withinthe gall bladder. In some embodiments of the invention, the guiding rodis used for pushing (808) gall stones distally in the gallbladder priorto or during deployment of the filter device.

FIG. 6 is a top view of a filtering device 600 in situ, in accordancewith an exemplary embodiment of the invention. In an embodiment of theinvention, the device 600 is blocking/filtering gall stones 602 of aspecified minimum size and preventing them from leaving the gallbladder.

FIG. 9A is a side view of a filtering device 900 with leaves 906 of afiltering portion 902 and a split stopper 904, where the filteringportion 902 and the stopper 904 are connected by a tail 912, inaccordance with an exemplary embodiment of the invention. In anembodiment of the invention, the leaves 906 are formed of the singlewire of the device by repeated curves which give a leaf-like, but open,shape. In some embodiments of the invention, there are a plurality offormed leaves, for example anywhere from 2-7 leaves. Optionally, thereare more leaves. In an embodiment of the invention, the number ofleaves, which optionally overlap at least partially helps to determinethe size of particles that are filtered by the filtering portion,wherein as the number of leaves increase, optionally overlapping, impedesmaller and smaller stones are filtered. In some embodiments of theinvention, the number of leaves helps to determine the amount ofpressure exerted by the filter device on the surrounding body tissue,where generally the more leaves there are, the less pressure exerted onthe body by any single one. In an embodiment of the invention, theleaves 906 are ovoid, spherical, circular or oblong shaped, as examples.In some embodiments of the invention, the tail 912, or a portion of it,is welded to at least one of the leaves 906. In some embodiments of theinvention, any loose ends of the wire are attached, optionally bywelding, such that there are no loose ends in a finished filteringdevice.

In some embodiments of the invention, the filtering device 900 has twostopper structures 908, 910 instead of one, such as shown in FIG. 5B. Inan embodiment of the invention, the two stopper 908, 910 stopperconfiguration increases the contact area (over having just one stopper)between the filtering device 900 and a distal wall of the gallbladderand/or reduce pressure exerted on the stopper, generally, andsubsequently the amount of counter-force applied by the device 900 onthe gallbladder. In some embodiments of the invention, the filteringportion 902, the tail 912 and the stopper 904 are disposed entirelywithin the gallbladder, substantially uncompressed or shaped by thewalls of the gallbladder, when implanted. In some embodiments of theinvention, at least the two stopper structures 908, 910 and the tail 912are all co-planar. In some embodiments of the invention, having at leasttwo tails enables the filtering device 900 to adapt better to the sizeand/or shape of the gallbladder relative to a filtering device with onlyone tail, at least because the plurality of tails are more articulate.In an embodiment of the invention, the split tail/stopper configurationprovides a deformation ability, optionally elastic deformation, to thefilter device, for example upon the exertion of axial pressure on thedevice. Optionally, the stopper and/or tail represent 10%-40% of thedevice's overall length.

In some embodiments of the invention, the tails are of differentlengths, for example to bias the filtering device in the gallbladderand/or to adapt the filtering device to a shape of the gallbladder. Insome embodiments of the invention, having a plurality of stoppersprovides redundancy in case at least one stopper is blocked fromreaching the distal wall of the gallbladder by debris (e.g. stones)within the gallbladder.

FIG. 9B is a side view of a filtering device 920 with large overlappingleaves 926 of a filtering portion 922, in accordance with an exemplaryembodiment of the invention. In an embodiment of the invention, theleaves 926 are configured to have a wider minor axis, in relation toother embodiments described herein, for example device 900. In anembodiment of the invention, the leaves 926 are ovoid or oblong shaped.In an embodiment of the invention, the tail/stopper are a variant of aleaf or petal, for example of generally similar shape to the leaves 926but elongated.

In some embodiments of the invention, a leaf 926 occupies 30° to 120° inradial circumference around the longitudinal axis of the filter device,is between 1 cm and 10 cm in length and/or between 20% and 60% of anominal gallbladder's length and/or up to 80% of a nominal gallbladder'smaximal diameter. These ranges are given as guidelines only, and actualfilter devices could be larger or smaller in any of the reciteddimensions.

In an embodiment of the invention, the leaves 926 are configured tooverlap in order to provide a filtering structure that will filter smalldiameter particulates, such as gallstones. It should be understood thatas the amount of leaf overlapping is increased, the smaller the stonesthat will be filtered, in an embodiment of the invention.

In an embodiment of the invention, a stopper 928 of the device 920 iscurved to minimize trauma to the patient and is connected to thefiltering portion 922 by a tail 924.

In some embodiments of the invention, the filtering portion 922, thetail 924 and the stopper 928 are disposed entirely within thegallbladder, substantially uncompressed or shaped by the walls of thegallbladder, when implanted.

FIGS. 10A-10C are side views of different stopper configurations, inaccordance with exemplary embodiments of the invention. It should beunderstood that the stopper configurations described with respect toFIGS. 10A-10C could be used with any of the filter devices describedherein. It should also be understood that in some embodiments of theinvention, the stopper portion (for example, those described in FIGS.10A-10C) of a filtering device is usable in a similar fashion to theblocking device 100 or portions 302, 322, 342 described elsewhereherein, that is, to push gallstones to the distal portion of thegallbladder prior to deployment and expansion of the filtering sectionat least to allow for unimpeded expansion of the filtering section. Insome embodiments of the invention, the stopper and/or the tail isconfigured to deform to provide compliance with various gallbladdersizes and/or geometries. Optionally, the stopper and/or tail designs arealso configured to deform in order to maintain or decrease force appliedto the gallbladder wall.

In some embodiments of the invention, the stoppers deploy in either twodimensions or three dimensions. Optionally, three-dimensional stoppersprovide more prevention of filter device movement, more pressurereduction against the gallbladder wall and/or more compliance togallbladder shape and/or exerted forces during use.

In an embodiment of the invention, FIG. 10A shows a stopper 1000 with amushroom-like configuration (biased towards the opening of thegallbladder) intended to increase the surface area of contact betweenthe filtering device and the wall of the gallbladder, thus decreasingthe pressure exerted by area of the device on the patient.

FIG. 10B shows a stopper 1010 configured with a spring-like shape whichcould optionally be resilient, absorbing force to dampen pressureexerted on the wall of the gallbladder in which the filtering device isdeployed.

FIG. 10C shows a stopper 1020 which is configured with concentriccircles. In an embodiment of the invention, the concentric circlesextend in three dimensions, for example extending perpendicular to thetail, increasing the contact area between the stopper and thegallbladder wall.

FIGS. 11A-11C are side views of a schematic deployment sequence of afiltering device 1100 using a delivery system 1150, in accordance withexemplary embodiments of the invention. In some aspects, at least someaspects of the sequence shown in FIGS. 11A-11C is similar to thatdescribed with respect to the delivery system 550 of FIGS. 5C-5D. In anaspect, the delivery system 1150 includes the use of a shaped tip 1152,optionally similar to tip 556 described with respect to FIGS. 5C and 5D,and follows a deployment methodology such as described with respect toFIG. 7 and FIG. 8, which assists with navigating within the body to theimplantation site in the gallbladder 104. In an aspect, the deliverysystem 1150 also includes an external catheter 1154 and/or a guide wire1156. Optionally, the filtering device 1100 is side-loaded into theexternal catheter 1154, on the side of an internal catheter on which thetip 1152 is disposed. Optionally, the filtering device 1100 is wrappedaround the internal catheter. In some aspects, the tip 1152 is threadedthrough apertures 1104 in at least a blocking section 1102 (shown inFIGS. 11B and 11C) of the filtering device 1100 before loading into theexternal catheter 1154.

In FIG. 11A, the guidewire 1156 is inserted into the patient andnavigated to the gallbladder 104 into which the filtering device 1100 isto be implanted, in an aspect. The external catheter 1154, containingthe filtering device 1100 (and/or any other component which needs to bedelivered to the implantation site) is placed over the guide wire 1154and advanced in a distal direction into and through the patient to thegallbladder 104, in some embodiments. In some embodiments, the guidewire1156 is used in conjunction with medical imaging to verify or determineproper/desired location of filtering device 1100 implantation. In someembodiments, the use of the guidewire 1156 enhances patient safety byreducing the likelihood of a part of the delivery system piercing and/orphysically damaging the gallbladder 104 wall. In some embodiments, theuse of the guidewire 1156 creates an ascertainable path of travel forthe filtering device 1100 and/or the delivery system, enhancing variousfacets of implantation such as pushing gall stones 102 away from thegallbladder 104 opening along a known and/or desirable path (optionallycoordinated with known location of gall stones 102).

FIG. 11B shows the beginning of filtering device 1100 deployment out ofthe external catheter 1154, wherein the blocking section 1102 has beenadvanced out of the external catheter 1154, or the external catheter1154 has been retracted, or both, and the blocking section 1102 has atleast partially expanded to engage and push gall stones 102 away fromthe gall bladder opening. FIG. 11C shows the tip 1152 and the blockingsection 1102 advanced distally and further into the gallbladder 104,pushing the gall stones 102 farther away from the gall bladder opening.In some embodiments, the external catheter 1154 would be retractedand/or the filtering device 1100 would be pushed out of the externalcatheter 1154 to fully deploy within the gallbladder 104 (i.e. theblocking section 1102, when the device 1100 is fully deployed, isdisposed near the distal wall of the gallbladder 104 while the filteringsection, shown in FIGS. 11B and 11C still contracted in the externalcatheter 1154, expands and is disposed near the gallbladder opening).Subsequently, the tip 1152 and/or the guidewire 1156 would be withdrawn,optionally through apertures 1104 in the filtering device 1100.

FIG. 12 is a side view of a filtering device 1200 with a generallyegg-shaped or ovoid body, in accordance with exemplary embodiments ofthe invention. In an aspect, it is configured such that the filteringdevice 1200 is formed and/or configured to and/or assumes a shape thatis approximately the same as the gallbladder 104 in which it isimplanted and, typically, the gallbladder is 104 egg-shaped. As withother filtering devices described herein, filtering device 1200 isadapted to expand (e.g. shape memory, inflation balloon, elastic/springycharacteristic) when expelled from a deployment system, such as anexternal catheter, as described elsewhere herein. The expandability ofthe filtering device 1200 enables the filtering device 1200 to expand toapproximately the size and/or shape of the gallbladder 104, trapping anygall stones 102 within or against the gallbladder 104 wall. In someembodiments, there is more structure of the device 1200, more denselyarranged near the gallbladder 104 opening such that a filtering functionis performed by the structure at least at that point. In some aspects,it is also conceived that the egg or ovoid shape, which closely mimicsthe natural shape of the gallbladder 104, reduces or eliminates (i.e.the filtering device 1200 free-floats, or nearly so, in the gallbladder104 while also occupying nearly all of the empty space within thegallbladder 104) the chances of pressure or localized pressure beingexerted on the wall of the gallbladder 104, enhancing patient comfortand safety.

In some aspects, the filtering device 1200 is a continuous coiled wireor filament which is formed into an egg-like or ovoid shape, with atleast one coiled loop to form a cage-like structure with a space thereinfor trapping gall stones 102. In some aspects, such as what is shown inFIG. 12, two ends of a linear wire are welded 1202 together to form thedevice's shape. In other aspects, such as shown and described in moredetail below with respect to FIGS. 15A-15B, joining rings are usedcreate the device shape from a plurality of wires or filaments. Itshould be understood that these are by way of example only, and thatconceivably any mechanism and/or technique which would result in anovoid or egg-like shape could be used.

As with other filtering devices described herein, filtering device 1200(and any of the filtering devices or “wires” described below) could bemade from a shape memory alloy like Nitinol®. They could also be madefrom metals, polymers, composites or any combination thereof. In someembodiments, wire means a wire or filament as conventionally understood,however, “wire” in some embodiments could mean material 2100, 2110 cut(e.g. laser) from a sheet 2102 or a tube 2112, such as shown in FIGS.21A-21B, and optionally welded into shape. In some embodiments, thereare layers of materials, for example a coating on the wires. Thethickness of the material is typically 0.05 mm-0.35 mm, but could bethinner and/or thicker (that is, the device isn't all the same thicknessof material) depending on the material being used and/or the shapeand/or the configuration of the filtering device.

FIG. 19 is a plan view of at least a part 1900 of a filtering device, inaccordance with an exemplary embodiment of the invention, which is whatat least a part of a filtering device might look like in asemi-manufactured state, for example, having just been cut from a sheetlike in FIG. 21A. In an exemplary embodiment, the part 1900 includes afiltering and/or blocking portion 1902 and an anchoring/neck/tail(depending on how the part 1900 is used) portion 1904.

FIG. 20A-20C are side views which provide examples of filtering devices2000, 2010, 2020 which could be made from one or more parts 1900, inaccordance with some exemplary embodiments of the invention. FIG. 20Ashows a filtering device 2000 which has two parts 1900 welded 2002together end to end at the neck portions 1904 i, 1904 ii such that thefiltering portions 1902 i, 1902 ii are disposed on opposite ends of theoverall device 2000. FIG. 20B shows a filtering device 2010 where theneck portions 1904 are bent into a circle at their ends and optionallywelded 2002 themselves (forming a “tail” similar to that shown in FIG.9A). FIG. 20C shows a filtering device 2020 constructed of part 1900where the ends of the neck 1904 are welded to each other to form aclosed loop (forming a “tail” similar to that shown in FIG. 9B).

FIG. 13 is a side view of a double layered egg-shaped filtering device1300, in accordance with exemplary embodiments of the invention. In someaspects, the filtering device 1300 is similar to the filtering device1200, but with an internal blocking portion 1302 disposed in an interiorspace of the filtering device 1300 near the gallbladder 104 opening. Theblocking portion 1302 operates to filter gall stones 102 alternativelyand/or additionally to the outer portion (which is structurally similarto filtering device 1200) of the filtering device 1300. In some aspects,the blocking portion 1302 and the outer portion are a continuous wire orfilament. In some aspects, the blocking portion 1302 is a separatestructure attached to the outer portion. Optionally, the blockingportion 1302 is also egg-shaped. In some embodiments, the blockingportion 1302 and the outer portion are sequential in space rather thanaxially overlapping. In some embodiments, at least a portion of theblocking portion 1302 is contained within the outer portion but notaxially aligned.

FIG. 14 is a side view of an asymmetrically-meshed, egg-shaped filteringdevice 1400, in accordance with exemplary embodiments of the invention.In some embodiments, an outer portion of the filtering device 1400 issimilar to filtering device 1200, however, there is additionallyprovided a mesh structure 1402 on the side 1404 of the filtering device1400 which abuts the gallbladder 104 opening when the device 1400 isdeployed. In some aspects, gall stones 102 remain entrapped within theouter portion of the filtering device 1400 and are preventingadditionally and/or alternatively by the mesh structure 1402. In someembodiments, the “mesh” structure 1402 comprises a plurality of leaf orpetal shapes, optionally overlapping at least partially, such as otherleaf shapes described herein (particularly with respect to FIGS. 9A-9B).In some embodiments, at least a portion of the mesh structure 1402 islocated outside the outer ovoid or egg-shaped portion.

FIGS. 15A-15B are side views of ringed, egg-shaped filtering devices1500, 1550, in accordance with exemplary embodiments of the invention.FIG. 15A shows a filtering device 1500 comprised of a plurality ofwires, the ends of which are joined together by a joining ring 1506. Itshould be understood that while an inner wire 1502 and an outer wire1504 are shown, any number of wires could be used to construct filteringdevice 1500. Further, it should be understood that this filtering device1500 could optionally exhibit an egg or ovoid shape in three dimensionswhen it expands after deployment, rather than in the two dimensionsshown. In an aspect, the joining ring 1506 is positioned near thegallbladder 104 proximal end 1508 of the filtering device 1500, when thedevice 1500 is implanted.

In some embodiments, an indentation (shown as indentations 1558 in FIG.15B) is created by the wires 1502, 1504 being curved around and linkedtogether by the ring 1506, which in FIG. 15A lies within the interior ofthe filtering devices 1500. In some embodiments, the indentations and/orthe rings act to resist shape change away from the expanded/deployedconfiguration and back to the compressed configuration exhibited when inthe external catheter. For example, the proximal end 1508, if it becomeslodged within the gallbladder 104 opening could feel pressure from thewalls of the body lumen to compress, possibly to the point of losing itsovoid or egg-like shape. It is conceived that the indentation willcounter this urge to compress. This indentation, and also possibly theindentations shown in FIG. 15B, are optionally used to collect gallstones 102 which are loose outside the perimeter formed by the filteringdevice 1500, in some embodiments. In some embodiments, the space createdby the indentation enables the filtering device 1500 todistort/flex/adapt its shape upon deployment in the gallbladder 104, forexample if there are multiple gall stones 102 which obstruct fulldeployment of the filtering device 1500 or if the gall bladder 104itself is smaller than the fully expanded device. In some embodiments,the indentation is not at an end, but located elsewhere around theexterior of the filtering device 1500. It should be understood that anyof these above described embodiments could also be applied to any of theother filtering devices described herein, and of particular note,filtering device 1550.

FIG. 15B shows a filtering device 1550 which includes a plurality ofjoining rings 1556, 1560 which are used together to impart a slightlydifferent shape to filtering device 1550 than filtering device 1550.Overall, the filtering device 1550 still exhibits an ovoid or egg shape,but is symmetrically shaped with at least two opposing indentations 1558where the joining rings 1556, 1560 are located). As with the filteringdevice 1500, filtering device 1556 exhibits a three-dimensional egg orovoid shape, when expanded after deployment, in some aspects. In thefiltering device 1550 of FIG. 15B, the inner layer 1552 is formed fromtwo wires, with each end joined at a joining ring 1556, 1560, while theouter layer 1554 is constructed similarly.

FIG. 16 is a side view of a two layered filtering device 1600, inaccordance with exemplary embodiments of the invention. In some aspects,filtering device 1600 is provided with a gall stone pushing layer 1604and a filtering layer 1602. In some aspects, the pushing layer 1604 isdeployed/expanded before the filtering layer 1602 to reduce thelikelihood that a gall stone 102 passes into the biliary system beforethe filtering device 1600 can be properly/fully deployed, such asdescribed with respect to other filtering devices described herein (e.g.FIGS. 1A-4C). In some embodiments, the pushing layer 1604 is used tomove gall stones 102 away from the filtering device 1600 so that they donot impeded device 1600 expansion or block or contort expansion of thedevice. In some aspects, the pushing layer 1604 and the filtering layer1602 work together to provide filtering, to prevent gall stones 102 frommigrating into the biliary tree. Optionally, the pushing layer 1604 is afiner filter than the filtering layer 1602. In some embodiments, thepushing layer 1604 is similar to blocking layers or portions describedelsewhere herein.

In some aspects, the filtering device is provided with an anchoringportion 1606 or stopper, which spaces the pushing layer 1604 and thefiltering layer 1602 away from a distal wall of the gallbladder 104, andoccupying the length of the gallbladder 104 such that the blocking layer1604 and filtering layer 1602 remain close to, or abut, the gall bladderopening. A neck 1608 of the filtering device 1600 connects the anchoringportion 1606 to the blocking layer 1604. In some embodiments of theinvention, at least the neck 1608 is flexible to conform to a particulargallbladder's 104 geometry and/or to changes in size and/or shape of thegallbladder 104 due to being in a living being, and/or to debris orother materials within the gallbladder 104. In some embodiments of theinvention, the filtering device 1600, and/or any of the other filteringdevices described herein, do not apply any expansive force on the wallof the gallbladder 104. In some embodiments, at least the anchoringportion 1606 and the neck 1608 are a single bent wire or filament. Insome embodiments, the anchoring portion 1606 is comprised of multiplewires or other surface area increasing structures (such as at least onepad), to reduce localized pressure exerted by the filtering device 1600on the gallbladder 104 wall.

FIGS. 17A-17B are side views of a filtering device release configurationand a filtering device retained configuration of a filtering devicedeployment system, respectively, as described in more detail below.

FIGS. 17C-17D are side views of a schematic deployment sequence of afiltering device using a filtering device deployment system, inaccordance with exemplary embodiments of the invention.

For efficiency, FIGS. 17A-17D will be described in conjunction with FIG.18, a flowchart of a method 1800 of deploying a filtering device using afiltering device deployment system including at least a release wire1706, in accordance with an exemplary embodiment of the invention. FIGS.17C-17D show the progression of the deployment of a filtering device(e.g., any of the filtering devices described herein) wherein therelease wire 1706 is used to releasably retain a filtering device 1700within an external catheter 1702 during navigation and until thefiltering device 1700 is to be deployed. In some aspects, the releasewire 1706 is attached on a central cylinder 1708 (e.g. guiding rod) neara distal end of the central cylinder, proximal to a distal end of theexternal catheter 1702. In some embodiments, the release wire 1706 isattached to a ring 1704 located near and around the distal end of thecentral cylinder 1708. In some aspects, the release wire 1706 is biasedto be straight, such as shown in FIG. 17A, with a straight and un-tensedrelease wire 1706 but prior to deployment of the filtering device 1700is hooked (such as shown in FIG. 17B-17C).

In use, the filtering device 1700 is retained (1802) by the release wire1706 due to its configuration into a hooked shape (shown with thefiltering device 1700 in FIG. 17C and without the device, for clarity,in FIG. 17B). Upon retraction (1804) of the external catheter 1702and/or pushing (1806) of the central cylinder 1708 forward, the hookedrelease wire 1706 eventually clears the restraint put on it by theexternal catheter 1702, thereby causing the release wire 1706 to assumeits naturally straight configuration and subsequently releasing (1808)the filtering device 1700, shown in FIG. 17D. In some aspects, thehooked release wire 1706 is hooked through a filtering layer (or mostproximal layer) such that a blocking layer (or most distal layer) is notretained by the release wire, and can expand/deploy to start pushinggall stones 102 away from the gallbladder 104 opening. In some aspects,the external catheter 1702 and/or the central cylinder 1708 and/or anyguide wire or other part of the delivery system is retracted (1810) fromthe patient's body. In some aspects, it is conceived that holding therelease (1808) of the filtering device 1700 allows the attending medicalprofessional to be satisfied, using for example medical imaging, withthe location of the device 1700 implantation before effectuatingseparation of the filtering device 1700 into the gallbladder.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range. Further, described ranges areintended to include numbers outside any range described withinstatistical error and/or inherent measurement equipment limitations.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

1-26. (canceled)
 27. A method of deploying a filtering device in agallbladder, comprising: navigating a guide wire to an implantation sitein the gallbladder; placing an external catheter containing thefiltering device over the guide wire; advancing the external catheterand the filtering device in a distal direction along the guide wire tothe implantation site; and, deploying at least a blocking portion of thefiltering device out of the external catheter.
 28. A method according toclaim 27, wherein the deploying includes pushing at least one gall stoneaway from a gallbladder opening towards a distal wall of the gallbladderwith the blocking portion.
 29. A method according to claim 27, whereinplacing further comprises placing over the guide wire, a tip on thedistal end of the external catheter.
 30. A method according to claim 29,wherein the advancing further comprises using the tip to assist with theadvancing to the implantation site.
 31. (canceled)
 32. A methodaccording to claim 27, further comprising retracting the externalcatheter to deploy at least the blocking portion of the filteringdevice.
 33. (canceled)
 34. A filtering device for implantation in agallbladder, comprising: an egg or ovoid shaped body configured totransition from a collapsed configuration to an expanded egg or ovoidshaped configuration; wherein the body is formed from at least one eggor ovoid shaped coil of wire forming an interior space within the coilfor trapping gall stones.
 35. A filtering device according to claim 34,wherein the body does not exert pressure, in the expanded configuration,on a wall of the gallbladder.
 36. A filtering device according to claim34, comprised of a single wire.
 37. A filtering device according toclaim 34, wherein the coil of wire is denser on a proximal end of thefiltering device near an opening of the gallbladder.
 38. (canceled) 39.A filtering device according to claim 34, wherein two ends of a linearcoil of wire are welded together to form the ovoid or egg shape.
 40. Afiltering device according to claim 34, wherein the coil of wire is 0.05mm-0.35 mm thick.
 41. A filtering device according to claim 34, furthercomprising an internal blocking portion disposed in the interior spaceof the filtering device.
 42. (canceled)
 43. A filtering device accordingto claim 41, wherein the internal blocking portion is egg or ovoidshaped.
 44. A filtering device according to claim 34, further comprisinga mesh structure disposed on a proximal side of the filtering devicenear a gallbladder opening.
 45. A filtering device according to claim44, wherein the mesh structure comprises a plurality of leaf or petalshapes.
 46. A filtering device according to claim 34, wherein the bodyis formed from a plurality of wires, the ends of which are joinedtogether by at least one joining ring.
 47. A filtering device accordingto claim 46, further comprising at least one indentation formed by acurvature of the wires.
 48. A filtering device deployment system,comprising: an external catheter formed in a hollow cylindrical shape; acentral cylinder configured for insertion into and through the externalcatheter; a filtering device; and, a release wire, biased to bestraight, disposed near a distal end of the central cylinder and withinthe external catheter, wherein the release wire is releasably hookedaround a portion of the filtering device to retain the filtering devicewithin the external catheter.
 49. A filtering device deployment systemaccording to claim 48, further comprising a ring disposed near andaround the distal end of the central cylinder.
 50. A filtering devicedeployment system according to claim 49, wherein the release wire isattached to the ring.